Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorPusan National University Hospital
About this trial
This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan-Gyeongnam region. It seeks to determine whether discontinuing 5-ASA is a safe treatment strategy in modern IBD management.
Eligibility criteria
Qualifiers
Diagnosis
Treatment Status
Patients who have been continuously treated with biologic agents (e.g., anti-TNF agents, integrin inhibitors, JAK inhibitors) or immunomodulators (e.g., azathioprine, methotrexate) for at least three months.
Patients who have been on a stable dose of 5-ASA (mesalamine) for at least three months before study enrollment.
Disqualifiers
Patients with severe active UC or CD at the time of study enrollment.
Patients who have been recently hospitalized for IBD-related reasons or undergone IBD-related surgery within three months before enrollment.
Patients who have had dose modifications of biologics, immunomodulators, or corticosteroids for IBD within three months before enrollment.
Patients receiving concomitant therapy with other medications that may affect disease activity (e.g., additional anti-inflammatory agents, IBD-related antibiotics).
Trial design
Treatments tested in this trial
- Discontinuation of 5-ASA
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov